Open-label, Single-arm, Multicenter, Phase III Trial to Assess the Antitumor Activity and Safety of Cetuximab When Given in Combination With Radiotherapy for the Treatment of Locally Advanced Squamous Cell Carcinoma of the Head and Neck in Chinese Subjects
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Squamous Cell Carcinoma of the Head and Neck
- Sponsor
- Merck KGaA, Darmstadt, Germany
- Enrollment
- 70
- Locations
- 8
- Primary Endpoint
- Best Overall Response (BOR)
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
Primary objective: to assess the antitumor activity and safety profile of cetuximab when given in combination with radiotherapy (RT) for the treatment of locally advanced squamous cell carcinoma of the head and neck (SCCHN) in Chinese subjects.
Secondary objective: to assess the pharmacokinetic (PK) profile and immunogenicity of cetuximab in Chinese subjects.
Further objective: to identify for cetuximab potential predictive biomarkers of response and safety.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Inpatient greater than or equal to (\>=) 18 years of age
- •Pathologically proven squamous cell carcinoma arising in the oropharynx, hypopharynx or larynx
- •Stage III or IV disease with an expected survival of at least 12 months
- •Medically suitable to withstand a course of concomitant boost RT
- •Presence of at least 1 bi-dimensionally measurable lesion identified either by computed tomography (CT) scan or magnetic resonance imaging (MRI) according to modified World Health Organization (WHO) criteria
- •Karnofsky Performance Status (KPS) \>=80 at trial entry
- •Neutrophils \>=1.5\*10\^9/Liter (L), platelet count \>= 100\*10\^9/L, hemoglobin \>= 90 gram/liter (g/L)
- •Total bilirubin less than or equal to (\<=) 2\*upper limit of normal (ULN); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \<= 3\*ULN
- •Serum creatinine \<=133 micromole/liter (mcmol/L)
- •Serum calcium within normal range
Exclusion Criteria
- •Evidence of distant metastatic disease
- •Squamous cell carcinoma arising in the nasopharynx or oral cavity
- •Receipt of prior systemic chemotherapy within the last 3 years
- •Previous surgery for the tumor under study other than biopsy
- •Receipt of prior RT to the head and neck
- •Currently receiving RT as part of a postoperative regimen following primary surgical resection
- •Planned neck dissection after trial RT
- •Active infection (infection requiring IV antibiotics), including active tuberculosis, or known and declared human immunodeficiency virus (HIV)
- •Uncontrolled diabetes mellitus, pulmonary fibrosis, acute pulmonary disorder, interstitial pneumonia, cardiac failure or liver failure
- •Uncontrolled hypertension defined as systolic blood pressure \>=180 millimeter of mercury (mmHg) and/or diastolic blood pressure \>=130 mmHg under resting conditions
Outcomes
Primary Outcomes
Best Overall Response (BOR)
Time Frame: Baseline until the date of first documented progression or discontinuation from the study due to any cause, assessed every 3 months following the 8 weeks after the end of RT visit until the end of trial (EOT) visit
Best overall (objective) response was defined as the occurrence of complete response (CR) or partial response (PR) based on the investigator's assessment according to modified World Health Organization (WHO) criteria confirmed at a repeat assessment performed no less than 28 days after the criteria for response were first met. CR was defined as disappearance of all index lesions. PR was defined as a 50% or more decrease in the sum of the products of diameters (SOPD) of index lesions compared to the baseline SOPD, with no evidence of PD.
Secondary Outcomes
- Progression-Free Survival (PFS)(Baseline up to disease progression or withdrawal or 12 weeks after the last radiotherapy of the last participant)